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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 200MG **Federal Regist...DOSAGE - TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19758
DOSAGE - SUSPENSION;ORAL - 50MG/ML
USFDA APPLICATION NUMBER - 203479
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Clozapine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Clozapine manufacturer or Clozapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clozapine manufacturer or Clozapine supplier.
A Refraxol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Refraxol, including repackagers and relabelers. The FDA regulates Refraxol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Refraxol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Refraxol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Refraxol supplier is an individual or a company that provides Refraxol active pharmaceutical ingredient (API) or Refraxol finished formulations upon request. The Refraxol suppliers may include Refraxol API manufacturers, exporters, distributors and traders.
click here to find a list of Refraxol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Refraxol DMF (Drug Master File) is a document detailing the whole manufacturing process of Refraxol active pharmaceutical ingredient (API) in detail. Different forms of Refraxol DMFs exist exist since differing nations have different regulations, such as Refraxol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Refraxol DMF submitted to regulatory agencies in the US is known as a USDMF. Refraxol USDMF includes data on Refraxol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Refraxol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Refraxol suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Refraxol Drug Master File in Japan (Refraxol JDMF) empowers Refraxol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Refraxol JDMF during the approval evaluation for pharmaceutical products. At the time of Refraxol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Refraxol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Refraxol Drug Master File in Korea (Refraxol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Refraxol. The MFDS reviews the Refraxol KDMF as part of the drug registration process and uses the information provided in the Refraxol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Refraxol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Refraxol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Refraxol suppliers with KDMF on PharmaCompass.
A Refraxol CEP of the European Pharmacopoeia monograph is often referred to as a Refraxol Certificate of Suitability (COS). The purpose of a Refraxol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Refraxol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Refraxol to their clients by showing that a Refraxol CEP has been issued for it. The manufacturer submits a Refraxol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Refraxol CEP holder for the record. Additionally, the data presented in the Refraxol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Refraxol DMF.
A Refraxol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Refraxol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Refraxol suppliers with CEP (COS) on PharmaCompass.
A Refraxol written confirmation (Refraxol WC) is an official document issued by a regulatory agency to a Refraxol manufacturer, verifying that the manufacturing facility of a Refraxol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Refraxol APIs or Refraxol finished pharmaceutical products to another nation, regulatory agencies frequently require a Refraxol WC (written confirmation) as part of the regulatory process.
click here to find a list of Refraxol suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Refraxol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Refraxol API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Refraxol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Refraxol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Refraxol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Refraxol suppliers with NDC on PharmaCompass.
Refraxol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Refraxol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Refraxol GMP manufacturer or Refraxol GMP API supplier for your needs.
A Refraxol CoA (Certificate of Analysis) is a formal document that attests to Refraxol's compliance with Refraxol specifications and serves as a tool for batch-level quality control.
Refraxol CoA mostly includes findings from lab analyses of a specific batch. For each Refraxol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Refraxol may be tested according to a variety of international standards, such as European Pharmacopoeia (Refraxol EP), Refraxol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Refraxol USP).
